Method of using an ophthalmic surgical sponge

ABSTRACT

A method of using an ophthalmic surgical sponge is described. The sponge includes a base and a corneal shield assembly. The base allows absorption of corneal fluid during eye surgery. The corneal shield assembly is used as an absorption structure and a structure to protect the corneal cap which is formed during eye surgery, particularly in surgeries that remove tissue from the corneal stroma. The corneal shield assembly protects the corneal cap as well as the hinge of the flap during the actual tissue removal from either a laser or other tissue removing means. Thus, the corneal cap is protected from scatter rays from the laser or other debris created from tissue removal of the cornea. Wetting the ophthalmic sponge creates a co-hesive seal so that the corneal shield assembly can seal the corneal cap securely. This seal is removable after the surgery is completed to re-expose the corneal cap and replace the cap on the cornea.

FIELD OF THE INVENTION

This invention relates generally to a method of using a medical devicein ophthalmic surgery. More particularly, this invention relates to amethod of using a surgical ophthalmic sponge in laser refractive surgeryor other similar surgery where the sponge protects the corneal cap whileabsorbing excess fluid and blood from the surgery.

BACKGROUND OF THE INVENTION

In the medical arts, refractive surgery is a term used for a group ofvarious surgical procedures that alter relationships of the focusingcomponents of the eye in an attempt to bring light to a sharp focalpoint on the retina without the assistance of the use of glasses orcontact lenses. Possible options for refractive surgery are radialkeratectomy (RK), automated lamellar keratoplasty (ALK), photorefractivekeratectomy (PRK) and laser assisted in-situ keratomileusis (LASIK).

The procedure of automated lamellar keratoplasty has been performedsince about 1949. However, only in recent years has it improved as aresult of advancements in equipment. To treat myopia, a sophisticatedinstrument referred to as an automated microkeratome is used to foldback a thin superficial layer of the cornea. This layer is called thecorneal cap. Under this cap, a predetermined amount of corneal tissue isremoved from the center of the cornea with the microkeratome blade. Thecap is then folded back into place without the need for sutures. Removalof the central corneal tissue allows flattening of the cornea thusreducing nearsightedness.

In LASIK surgery, a corneal cap is fashioned by the microkeratome aspreviously indicated. The reshaping of the corneal is accomplished withthe laser. The bed of the cornea under the cap is flattened or re-moldedto correct for areas of shortsightedness, farsightedness, and astigmatism. After the central cornea is re-molded by the laser, the capis folded back over the central cornea and allowed to heal in placewithout any need for sutures. The patient is very comfortable afterwardsand can return to normal activities by the next day. Generally, sight isrestored within that following day.

The drawback of these procedures, however, is that the corneal cap isunprotected during the tissue removal or re-molding portion of surgery.The corneal cap can become distorted or contaminated with excess fluidand blood during the surgery. The corneal cap needs to be kept clean andprotected during the surgery.

Thus, there remains a need to provide a method that will allow excessfluid and blood to be absorbed during these types of surgery as well asprotect the corneal cap prior to repositioning on the cornea.

SUMMARY OF THE INVENTION

The present invention avoids the disadvantages of the prior art byallowing the corneal cap to be protected and excess fluid and blood tobe absorbed during eye surgery. Accordingly, there is provided in thepresent invention a method of using a surgical sponge having a basehaving a top, and a bottom. The ophthalmic surgical sponge also includesa corneal shield assembly. The corneal shield assembly may be part ofthe base or a separate component. The corneal shield assembly may havean inner flap portion, and a posterior flap portion for protecting thecorneal cap during eye surgery. If the corneal shield assembly is aseparate component, the corneal shield assembly is preferably attachedto the base. It is not required that the assembly be attached and it maybe a separate component. The corneal shield assembly could be aone-piece unitary structure or two separate pieces to comprise theanterior and posterior flap portions. The ophthalmic surgical sponge canalso include a hinge that would connect the anterior flap portion to theposterior flap portion. The hinge allows the flap portions to rotate andcover the corneal cap during eye surgery. Once the ophthalmic sponge iswetted with a solution, the anterior and posterior flap portions cancohesively seal the corneal cap thereby permitting further protection.The cohesive seal is releasable and the anterior and posterior flaps canbe removed to expose the corneal cap at the end of the eye surgery. Thisprotection allows the corneal cap to avoid scatter rays and other debrisfrom laser ablation or other tissue removal procedures. Once the cornealcap is re-exposed it is replaced back on the cornea and the operation iscompleted. The base allows absorption of the fluid around the corneapreventing under correction of laser ablation. The corneal shieldassembly could also include a flat edge on the posterior flap portionwhich protects the hinge of the corneal cap. The flat edge is designedto cover the shape of the hinge of the corneal cap.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an ophthalmic surgical sponge of thepresent invention.

FIG. 2 is a left-sided elevational view of the sponge.

FIG. 3 is a right-side elevational view of the sponge of FIG. 1.

FIG. 4 is a front-elevational view of the sponge of FIG. 1.

FIG. 5 is a top-plane view of the sponge of FIG. 1.

FIG. 6 is a bottom-plane view of the sponge of FIG. 1.

FIG. 7 is a perspective view of the sponge in FIG. 1 in use on the eye.

FIG. 8 is the sponge shown in FIG. 7 protecting the corneal cap duringeye surgery.

FIG. 9 is a picture of the eye after the sponge in FIG. 8 has beenremoved and the corneal cap replaced.

FIG. 10 is an alternate embodiment of an ophthalmic surgical sponge withthe corneal shield assembly having multiple components.

FIG. 11 is another alternate ophthalmic surgical sponge with the cornealshield assembly attached to the base.

FIG. 12 is a modified version of the sponge in FIG. 11.

FIG. 13 is an alternate embodiment of an ophthalmic surgical sponge withthe corneal shield assembly detached from the base.

FIG. 14 is an alternate embodiment of an ophthalmic surgical spongewhere the base forms the corneal shield assembly.

DETAILED DESCRIPTION

The ophthalmic surgical sponge for protection of a corneal cap inaccordance with the subject invention is identified generally by thenumeral 2 in FIGS. 1-8. In this preferred embodiment sponge 2 includes abase 4 and a corneal shield assembly 6. Base 4 and corneal shieldassembly 6 can either be attached or detached from each other to provideprotection of the corneal cap. In addition, the corneal shield assemblymay be formed solely by the base such as shown in FIG. 14. Thus, thebase may be the corneal shield assembly. Preferably, base 4 and cornealshield assembly 6 are attached and a unitary structure. However, thebase and the corneal shield assembly do not need to be attached toprovide the primary function of protecting the corneal cap and otherstructures could be provided. For example, such structures may include aseparate base and a solitary detached corneal shield assembly, a basewith multiple corneal shield assemblies, and a structure having a basethat is the corneal shield assembly. These embodiments will be furtherdescribed herein.

Base 4 is preferably circular in shape in the form of a ring as shown inFIGS. 1 and 3. However, the base can be any geometric shape such asrectangular, semi-circle, ellipse, triangular, square and other suchpolygon structures. Examples of these shapes include those shown in FIG.11, FIG. 13 and FIG. 14. Base 4 has a top 22, a bottom 24 and a side 26.The base further may include a hole 30 therethrough defined by a surface8 that allows placement of the base on the eye such that access to thecornea is available even when the ring base is placed over the eye. Thehole is not necessary as shown in FIGS. 13-14. If used, hole 30 has aninside diameter D. Inside diameter D is between about 8 mm to about 16mm. Preferably, inside diameter D is 11 mm or 13 mm to fit themajority-sized human cornea. Preferably, base 4 is circular in shape tofit around the cornea and provide maximum operating working space to thesurgeon. The base's primary function is to absorb fluid around thecornea thereby preventing undercorrection of laser ablation. However,the base does provide protection to the corneal cap.

Corneal shield assembly 6 further includes an interior flap portion 10and a posterior flap portion 12. Again, corneal shield assembly 6 ispreferably a unitary structure with base 4. However, corneal shieldassembly 6 can be a separate component to the base. The corneal shieldassembly can have any geometric shape including rectangular, square,triangular, semi-circle, ellipse, or any other polygon structure.However, the preferred shape of anterior flap portion 10 and posteriorflap portion 12 is circular shaped to mimic the circular nature of thecorneal cap.

When the corneal shield assembly is attached to ring base 4 a bridge 20is formed between the corneal shield and the base. Bridge 20 is thelocation where the hinge of the corneal cap would lay during the eyesurgery. Preferably, corneal shield assembly 6 further includes a hinge14 that attaches posterior flap portion 10 to anterior flap portion 12.

Hinge 14 can be connected to anterior and posterior flap portions in anyposition. However, it is preferred that the hinge is centrally locatedbetween the anterior flap portion and the posterior flap portion. Thehinge's primary function is to provide connection between the posteriorand anterior flap portion and allow the posterior flap portion to coverthe corneal cap. Preferably, hinge 14 is rectangular in shape but canassume any shape necessary to connect the posterior flap to the anteriorflap portion. Additionally, hinge 14 is not required for protection ofthe corneal cap as later will be shown in the alternative embodiments.Hinge 14 merely provides a means of allowing the posterior flap portionto controllably and easily fold over the corneal cap which is laid onthe anterior flap portion. There are other ways of providing theflexibility and motion of the posterior flap portion. For example, suchmeans include a solitary base with a detached foldable corneal shieldassembly, a foldable corneal shield assembly attached to a base, a basethat is the corneal shield assembly having a foldable section, or simplytwo pads placed together.

Posterior flap portion further includes a flat edge 16. Flat edge 16provides protection to the hinge of the corneal cap. As shown in FIG. 7,corneal cap 40 lays on anterior flap portion 10 thereby exposing acorneal stroma 44. However, corneal cap may lay on the base or anyportion of the corneal shield assembly. The base preferably lays in thelimbus area which is located between the cornea 36 and sclera 34 of eye32 as shown in FIG. 7. FIG. 8 illustrates protection of the corneal capand hinge. A laser beam 46 or other instrument is used to remove tissuein the corneal stroma. Ring base 4 absorbs fluid around the corneapreventing undercorrection of laser ablation. In the preferredembodiment, the posterior flap portion is rotated over to cover thecorneal cap. Depending on the structure of the ophthalmic sponge, thecorneal shield assembly or base may be folded, placed, rolled and/orsealed to protect the corneal cap. Flat edge 16 covers and protects thehinge of the corneal cap 42. Thus, the corneal cap is protected fromscatter rays and debris from the laser or other instrument that isactually removing the tissue of the corneal stroma. By using a wettingagent a cohesive seal is formed between the anterior and posterior flapportions. Preferably, the wetting agent is a balanced salt solution.However, other solutions can be used as a wetting agent such as normalsaline solution, filtrated water, or any other type of liquid ormedication. The cohesive seal can be broken and the posterior flapportion can be rotated back into its original position thereby exposingthe corneal cap. After the removal of the tissue is completed, thecorneal cap is replaced back on cornea 36 as shown in FIG. 9. At thispoint, the ophthalmic sponge is removed.

The ophthalmic surgical sponge can also have alternative structures asshown in FIGS. 10-14. More particularly, an alternative embodiment of anophthalmic surgical sponge 50 is shown in FIG. 10. Sponge 50 includes anabsorption ring 52, and anterior pad 54 and a posterior pad 56. Thecorneal cap is placed between the pads to allow protection of thecorneal cap during surgery. An eye insertion space 48 allows access tothe eye. Thus, the corneal shield assembly may comprise multiplecomponents and be detached from the base.

As shown in FIG. 11, an ophthalmic sponge 60 can have a folding pad 62,either detached or as shown in FIG. 11, attached to an absorption ring70. Pad 62 would have a front section 66 and a back section 68. Thecorneal cap would lay on front section 66 and back section 68 wouldcover the corneal cap after being folded along a folding line 64. Theeye would be accessible by an eye insertion space 61. Thus, the cornealshield assembly does not require the hinge to cover and fold over thecorneal cap for protection.

FIG. 12 illustrates another alternate embodiment of an ophthalmicsurgical sponge 72. Sponge 72 comprises a sponge ring 74, a pad 76 thatcan be either attached or as shown detached to ring 74. Pad 76 can alsohave a cut portion 78 that would allow ease of folding pad 76 andcreating a cap section 80 and a cover section 82. Cover section 82 wouldcover the corneal cap while the corneal cap rests on cap section 80. Theeye would be accessible by an eye insertion area 71.

FIG. 13 illustrates another embodiment of an ophthalmic surgical sponge90. Sponge 90 comprises a base 92 and a heel pad 94. Heel pad 94 can beattached or as shown detached from base 92. An eye insertion area 98 isformed by base 92. The sponge is placed adjacent to the eye. The cornealcap is laid on the base at an insertion area 96 and pad 94 is placed onthe base to cover the corneal cap. Thus, the base can be various shapessuch as a semi-circle.

FIG. 14 is an alternate embodiment of an ophthalmic surgical sponge 100where a base 102 forms or is the corneal shield assembly. Base 102 formsan eye insertion area 104 to enable the sponge to be adjacent to theeye. Base 102 can be folded along a folding line 108 to cover thecorneal cap after the corneal cap is placed on the base at an insertionarea 106. A portion 110 of the base covers or is folded over the cornealcap to protect it during surgery. Thus, the base can be the cornealshield assembly.

Preferably, the ophthalmic surgical sponge is a unitary structure. Thesponge is preferably made of a lint-resistant material. Such alint-resistant material can be selected from the group consisting ofpolyvinyl alcohol, polyvinyl acetate, and combinations thereof. However,other such lint-resistant materials can be used in addition to thesepreferred materials. These materials are preferred due to their naturaladhesion in creating a cohesive seal when wet.

Preferably, base 4 is connected to corneal shield assembly 6 at side 26.This positioning is not necessary for the corneal shield assembly toprotect the corneal cap, however, it is preferred that the ophthalmicsponge is a unitary structure in order to facilitate ease of use for thesurgeon and avoid a plurality of small objects surrounding the operatingsite.

The method of using an ophthalmic surgical sponge of the presentinvention for corneal cap protection is relatively straight-forward. Theeye is incised to create a corneal cap 42. The first step in using thesponge is to hold the ophthalmic sponge and place the sponge adjacent toor on eye 32 adjacent to the cornea. The corneal cap is then peeled backand placed preferably on the anterior flap portion of the corneal shieldassembly. However, the corneal cap may be placed on the base or otherportions of the corneal shield assembly. The corneal shield assemblyand/or the base can then either be wetted or used to cover the cornealcap. Preferably, the step of covering the corneal cap includes theposterior flap portion. Depending on the structure of the corneal capassembly, the corneal cap assembly can either be folded or used tosimply cover the corneal cap. In the preferred embodiment, where a hingeis utilized, the posterior flap portion is folded over to cover andprotect the corneal cap. Flat edge 16 covers and protects a hinge 42 ofthe corneal cap from debris and laser scatter during the eye surgery. Ifthe ophthalmic sponge is wetted, the corneal shield assembly will createa cohesive seal, sealing and protecting the corneal cap. Preferablysealing between the posterior and anterior flap portions is done. Theseal is removable and the hinge allows ease of removing the posteriorflap portion from the anterior flap portion thereby re-exposing thecorneal cap. Alternatively, when the corneal cap is placed on the base,a seal may be created between the base and the corneal shield assembly.Additionally, if the base is the corneal shield assembly as shown inFIG. 14, then the base will form a seal with itself. The base allowsabsorption of fluid around the corneal during the surgery. Due to theabsorptive nature of the corneal shield assembly, the anterior flapportion gives protection to the corneal cap as well as preventingconjunctive fluid from building up. In addition the anterior flapportion protects the epithelium. The posterior flap portion protects thecorneal cap from scatter rays and other debris when folded over to coverthe corneal cap. After the corneal cap is re-exposed, the corneal cap isplaced back on the cornea, at the end of the operation, for the eye tobegin healing.

The embodiments depicted in the Figures are intended to merely beexemplary and are not intended to depict all possible ophthalmicsurgical sponges used for protecting the corneal cap. Rather, sponge 2which contains ring base 4 and corneal shield assembly 6 can be used inany configuration having the appropriate dimensions and desired shape tofacilitate protection of the corneal cap during eye surgery. The abilityto absorb fluid from the eye and protect the corneal cap with the hingeof the corneal cap is greatly facilitated by the present invention. Thepresent invention enables the surgeon to use a device that performs thefunctions of both a sponge for absorbing fluid and a shield forproviding protection of the corneal cap during eye surgery.

What is claimed is:
 1. A method of using an ophthalmic surgical spongefor corneal cap protection, comprising the steps of: (a) holding anophthalmic sponge of the type including a base, and a corneal shieldassembly; and (b) placing said sponge on the eye.
 2. The method of claim1 further comprising the step of placing the corneal cap on said base.3. The method of claim 1 further comprising the step of placing thecorneal cap on said corneal shield assembly.
 4. The method of claim 3,wherein said corneal cap placement step further includes the step ofplacing the corneal cap on said anterior flap portion.
 5. The method ofclaim 3 further comprising the step of protecting the corneal cap duringeye surgery by covering the corneal cap with said corneal shieldassembly.
 6. The method of claim 1 further comprising the step ofabsorbing fluid around the cornea during eye surgery with said base. 7.The method of claim 1 further including the steps of adding a wettingagent to said ophthalmic sponge and sealing the corneal cap between saidcorneal shield assembly.
 8. The method of claim 7 wherein said wettingagent is a balanced salt solution.
 9. The method of claim 1 furtherincluding the steps of adding a wetting agent to said ophthalmic spongeand sealing the corneal cap between said base and said corneal shieldassembly.
 10. The method of claim 7 wherein said sealing step furtherincludes the step of re-exposing the corneal cap.
 11. The method ofclaim 10 further including the step of removing said ophthalmic spongefrom the eye.
 12. A method of using an ophthalmic surgical sponge forcorneal cap protection, comprising the steps of: (a) holding anophthalmic sponge of the type including a base having a top, a side anda bottom, and a corneal shield assembly having an anterior flap portionand a posterior flap portion; (b) placing said ophthalmic sponge on theeye such that the cornea is accessible; and (c) placing the corneal capon said corneal shield assembly.
 13. The method of claim 12 wherein saidophthalmic sponge placing step further includes the step of positioningsaid ring base on the limbus of the eye between the cornea and sclera.14. The method of claim 12 wherein said corneal cap placing step furtherincludes the step of placing the corneal cap on the anterior flapportion.
 15. The method of claim 14 further including the step offolding said corneal shield assembly to cover the corneal cap.
 16. Themethod of claim 15, further including the steps of adding a wettingagent and cohesively sealing the corneal cap between said anterior flapportion and said posterior flap portion.
 17. A method of using anophthalmic surgical sponge for corneal cap protection, comprising thesteps of: (a) holding an ophthalmic sponge of the type including a baseshaped in the form of a circular ring having a top, a side, a bottom,and a hole having an inside diameter, and a foldable corneal shieldassembly having an anterior flap portion and a posterior flap portionsuch that said side is mounted to said anterior flap portion, saidposterior flap portion having a flat edge; and a hinge connecting saidanterior flap portion to said posterior flap portion; (b) placing saidophthalmic sponge on the eye; (c) placing the corneal cap on saidanterior flap portion; and (d) rotating said posterior flap portion andcovering the corneal cap.
 18. The method of claim 17 further comprisingthe steps of wetting said anterior and posterior flap portion andsealing the corneal cap between said flap portions.
 19. The method ofclaim 17 further comprising the step of protecting the hinge of thecorneal cap with said flat edge.
 20. The method of claim 17 furthercomprising the steps of re-exposing the corneal cap and removing saidophthalmic sponge.